S0515 Combination Chemotherapy, Rituximab, and Bevacizumab in Treating Older Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma
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RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as rituximab and bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bevacizumab may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving combination chemotherapy together with monoclonal antibodies may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab and bevacizumab works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Biological: bevacizumab Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate |
Phase 2 |
Study Type: | Interventional |
Study Design: | Masking: Open Label Primary Purpose: Treatment |
Official Title: | Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell NHL |
- Progression-free survival at 1 year [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Response [ Designated as safety issue: No ]
Estimated Enrollment: | 70 |
Study Start Date: | June 2005 |
OBJECTIVES:
Primary
- Determine the 1-year progression-free survival rate in patients with bulky stage II or stage III or IV diffuse large B-cell lymphoma treated with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) and rituximab in combination with bevacizumab.
Secondary
- Determine the response rate (complete response, complete unconfirmed response, and partial response) and 2-year progression-free survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Correlate angiogenic biomarkers with outcome in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV, bevacizumab IV over 30-90 minutes, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at least every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* diffuse large B-cell lymphoma, meeting 1 of the following stage criteria:
- Bulky stage II
- Stage III
- Stage IV NOTE: *Adequate sections from the original diagnostic specimen must be available; needle aspiration or cytology are not considered adequate
- Bidimensionally measurable disease
- CD20-positive disease
- No prior indolent lymphoma, including histologic transformation or mixed histology with an indolent or nodular component
- No clinical evidence of CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3
- No bleeding diathesis or coagulopathy
Hepatic
- Not specified
Renal
- Creatinine < 2 times upper limit of normal
- No proteinuria ≥ +1 by dipstick or urinalysis OR
- Urine protein:creatinine ratio < 1.0 OR
- Urine protein < 1 g by 24-hour urine collection
Cardiovascular
- No uncontrolled hypertension
- No myocardial infarction within the past 6 months
- No unstable angina within the past 6 months
- No stroke within the past 6 months
- No arterial thrombosis within the past 6 months
- No clinically significant peripheral vascular disease
- Ejection fraction ≥ 45% by MUGA or 2-dimensional echocardiogram (2-D ECHO)
- No significant cardiac abnormality by MUGA or 2-D ECHO
Pulmonary
- No requirement for continuous supplemental oxygen
Gastrointestinal
- No abdominal fistula within the past 6 months
- No gastrointestinal perforation within the past 6 months
- No intra-abdominal abscess within the past 6 months
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- No known HIV positivity
- No history of hypersensitivity reaction to products containing polysorbate 20 (Tween 20), Chinese hamster ovary cell products, or recombinant human antibodies
- No traumatic injury within the past 28 days
- No serious or non-healing wound, ulcer, or bone fracture
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior antibody-based therapy for lymphoma
Chemotherapy
- No prior chemotherapy for lymphoma
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for lymphoma
Surgery
- More than 28 days since prior and no concurrent major surgery
- No prior solid organ transplantation
Other
Concurrent full-dose anticoagulants allowed for treatment of venous thrombosis provided the following criteria are met:
- INR in range (i.e., 2-3)
- Patient is on a stable dose of warfarin or low molecular weight heparin
- No bleeding or pathological condition that would confer a high risk of bleeding (e.g., tumor involving major vessels or known varices)
Show 159 Study Locations
Study Chair: | Alison T. Stopeck, MD | University of Arizona |
Study Chair: | Thomas P. Miller, MD | University of Arizona |
Additional Information:
No publications provided by Southwest Oncology Group
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office |
ClinicalTrials.gov Identifier: | NCT00121199 History of Changes |
Other Study ID Numbers: | CDR0000434636, U10CA032102, S0515 |
Study First Received: | July 19, 2005 |
Last Updated: | July 21, 2011 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Southwest Oncology Group:
stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma |
Additional relevant MeSH terms:
Lymphoma Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin Cyclophosphamide Rituximab Bevacizumab Doxorubicin Prednisone |
Vincristine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on October 16, 2012